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Medical Device

Quality Management in the Medical Device Industry

Because the very nature of medical device manufacturing is so closely related to patient health and well-being, companies are fighting what seems like an uphill battle against regulatory compliance.

As is the case with other industries that serve the public, the slightest nonconformance in a medical device’s quality could have catastrophic impacts to a company’s reputation and long-term performance in today’s news-travels-fast world. The industry is riddled with compliance and quality-related challenges, but manufacturers also have to account for cost and efficiency, all while attempting to break through the barriers of innovation.

Challenges aside, major opportunities are emerging for medical device manufacturers. Developing countries are constantly introducing new waves of demand. Companies are conjuring up interesting ways to capitalize on the areas of personalized medicine and the internet of things (IoT). And the industry itself is one of the greatest drivers of innovation and investment in the world.

Manufacturers ranging in size have been able to maintain their momentum with homegrown or point solutions designed to satisfy compliance requirements for mandates and standards such as ISO 13485 and FDA 21 CFR Part 11. This, however, is far from a sustainable long-term strategy.

Companies competing in life sciences industries thrive on their ability to deliver new products to market without being slowed down by regulatory compliance. Effectively moving from the ideation phase through design, production, and delivery requires uninhibited communication and collaboration across departments. Leading manufacturers are deploying enterprise quality management software as their quality and compliance hub, using it as an intermediary between existing product development and manufacturing operations solutions.

IQS’s Approach to Quality and Compliance in Medical Device Manufacturing

IQS has a long history of serving the medical device industry. Designed to accelerate new product development and introduction by building quality and compliance into the product lifecycle, IQS enterprise quality management software is the leading choice for medical device manufacturers.

The integrated QMS Software solution has capabilities such as mobile audits, document control, training, and supplier management, as well as modules like risk management and customer complaints to promote a closed-loop quality management ecosystem.

IQS’s modern approach to end-to-end quality management and compliance enables medical device manufacturers to focus on innovation and growth. Learn how IQS takes a platform approach to ISO 13485 compliance.



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